AU2007237298B2 - Deployment system for an endoluminal device - Google Patents

Deployment system for an endoluminal device Download PDF

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AU2007237298B2
AU2007237298B2 AU2007237298A AU2007237298A AU2007237298B2 AU 2007237298 B2 AU2007237298 B2 AU 2007237298B2 AU 2007237298 A AU2007237298 A AU 2007237298A AU 2007237298 A AU2007237298 A AU 2007237298A AU 2007237298 B2 AU2007237298 B2 AU 2007237298B2
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sheath
deployment
portion
catheter
material
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AU2007237298A
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AU2007237298A1 (en
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Steven R. Bruun
Edward H. Cully
James W. Mann
Mark J. Ulm
Michael J. Vonesh
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Gore W L and Associates Inc
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Gore Enterprise Holdings Inc
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Priority to US10/637,986 priority
Priority to AU2004207460A priority patent/AU2004207460B2/en
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Priority to AU2007237298A priority patent/AU2007237298B2/en
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Assigned to W. L. GORE & ASSOCIATES, INC. reassignment W. L. GORE & ASSOCIATES, INC. Request for Assignment Assignors: GORE ENTERPRISE HOLDINGS, INC.
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AUSTRALIA Patents Act 1990 COMPLETE SPECIFICATION Standard Patent Applicant: GORE ENTERPRISE HOLDINGS, INC. Invention Title: DEPLOYMENT SYSTEM FOR AN ENDOLUMINAL DEVICE The following statement is a full description of this invention, including the best method for performing it known to us: -2 TITLE OF THE INVENTION DEPLOYMENT SYSTEM FOR AN ENDOLUMINAL DEVICE CROSS REFERENCE TO RELATED APPLICATIONS 5 This application is a continuation-in-part of application Serial No. 10/346,598 filed January 17, 2003. FIELD OF THE INVENTION The present invention relates generally to 10 implantable medical device assemblies. In particular, the invention relates to means for deploying an endoluminal device within vascular or cardiac structures of an implant recipient. 15 BACKGROUND OF THE INVENTION Various implantable medical devices for repairing or reinforcing cardiac and vascular structures have been developed in recent years. Some of these devices can be implanted inside a particular vascular or cardiac 20 structure through so-called interventional, or endovascular, techniques. Interventional techniques involve surgically accessing the vascular system through a conveniently located artery or vein and introducing distal portions of a medical device assembly into the vascular 25 system through the arterial or venous access point. Once the medical device assembly is introduced into the vascular system, it is threaded through the vasculature to an implantation site while proximal portions of the assembly having manually operated control means remain 30 outside the body of the implant recipient. The medical device component of the assembly is then deposited at the implantation site and the remainder of the distal portion of the medical device assembly removed from the vascular system through the access point. 35 Exemplary interventional medical device assemblies include a catheter. The catheter can be used to precisely position the medical device at an implantation site as N:\Melboume\Cases\Patent\57000-57999\P57545 AU. 1\Spccis\P57545.AU I Spccification 2007-1 1-29.doc 30/11/07 -3 well as participate in deployment of the medical device at the implantation site. Some catheters have guidewires running their length to aid in positioning and deployment of the medical device. As an alternative to the s guidewire, a catheter may be coaxial with an inner sleeve running inside the length of the catheter. The inner sleeve is used to hold an implantable medical device in position while the outer catheter is pulled, causing deployment of the device. Handles, knobs, or other 10 manually operated control means are attached to the opposite end of the catheter in this assembly. Some implantable medical devices, such as stents, stent-grafts, or other endoluminal devices often require reconfiguration from an initial compacted form to an 15 expanded cylindrical configuration as the device is deployed at an implantation site. These devices can expand on their own by virtue of the design and composition of their structural elements or through the use of an inflatable balloon placed inside the devices. 20 Self-expanding endoluminal medical devices are maintained in a compacted configuration in a variety of ways. Some devices are maintained in a compacted configuration by simply confining the compacted devices inside a catheter, or similar tool. Other devices are 25 placed inside a sheath following compaction. In these assemblies, a control line is often used to assist in releasing the endoluminal device from the sheath. In U.S. Patent No. 6,352,561, issued to Leopold et al., a sheath is formed around an expandable endoluminal 30 device and a control line used to maintain the sheath around the endoluminal device. The sheath is formed by folding a length of polymeric material in half and stitching the opposing edges together with the control line. The stitching pattern permits the control line to 35 be removed from the sheath by pulling on a proximal end of the control line. As the control line becomes unstitched from the sheath, the endoluminal device is progressively N \Melboume\Cases\Patem\57000-57999\P57545.AU I\Specis\P57545.AU I Specification 2007-11-29.doc 30/11/07 -4 released from confinement within the sheath. The control line is removed from the assembly as a distinct entity while the sheath remains at the implantation site. In U.S. Patent No. 5.647.857, issued to Anderson et 5 al., an endoluminal device is held in a collapsed configuration over a catheter by a sheath. The assembly is provided with a control line having a free end and an end attached to a collar component of the catheter. The sheath is removed from the endoluminal device by pulling 10 on the control line. As the control line is pulled, it cuts through and splits the sheath material from distal end to proximal end. As the sheath splits open, the endoluminal device is freed to expand. Unlike Leopold et al., the control line remains mechanically attached to the 15 sheath and catheter assembly following deployment of the endoluminal device. In U.S. Patent No. 6,447,540, issued to Fontaine et al., a confining sheath is removed from around an endoluminal device with a control line that cuts through 20 and splits the sheath material when pulled by a practitioner, much like Anderson et al. As with Leopold et al, the control line can be completely removed from the assembly as a distinct entity. In U.S. Patent No. 5,534,007, issued to St. Germain 25 et al., a single-walled sheath that can collapse and shorten along its length is placed around a stent. As the distal portion of the sheath is retracted, it uncovers the stent. The uncovered stent is free to expand. A control line can be used to exert a pulling force on the 30 collapsible sheath as a means of removing the sheath from the stent. The control line remains attached to the sheath during and subsequent to deployment of the stent. In U.S. Patent No. 6,059,813, issued to Vrba et al, a double-walled confinement sheath for an endoluminal device 35 is described. In an assembly made of these components, the endoluminal device is placed over a catheter shaft in a collapsed configuration. An outer tube is placed in N.\Melboume\Cascs\Patent\57000-57999\P57545AUl \Spccis\P57545.AUI Specification 2007-1-29doc 30/11/07 -5 slidable relationship over the catheter. The distal end of the outer tube does not extend to cover the endoluminal device. Rather, the double walled sheath is placed over the collapsed endoluminal device. The inner wall of the 5 sheath is attached to the catheter shaft near the proximal end of the endoluminal device. The outer wall of the double-walled sheath is mechanically attached to the outer tube. Movement of the outer tube relative to the catheter causes the outer wall of the sheath to move past the inner 10 wall of the sheath. Movement of the outer tube in the proximal direction causes the sheath to retract and uncover the underlying endoluminal device. As the sheath retracts, the endoluminal device becomes free to expand. A control line is mechanically attached to the outer tube 15 and serves to move the outer tube and retract the sheath. None of these medical device assemblies utilize a control line that is integral with a confining sheath. Nor do these assemblies feature a sheath that is convertible to a control line as the sheath is removed 20 from around the endoluminal device. Such an integral control line and confining sheath would preferably be made of a continuous thin-walled material or composite thereof. The thin-walled material would be flexible and exert minimal restrictions on the flexibility of an underlying 25 endoluminal device. Thin-walled materials would also reduce the profile of the sheath and endoluminal device combination. An integral control line and confining sheath would simplify manufacture of control line - sheath constructs by eliminating the need to mechanically attach 30 the control line to the sheath. An integral control line and confining sheath would also eliminate concerns regarding the reliability of the mechanical attachment of the control line to the sheath. Additionally, inclusion of materials, composites, constructions, and/or assemblies 35 exhibiting compliance, compressibility, resilience, and/or expandability when positioned between the sheath constrained endoluminal device and the delivery catheter N \Melboume\Cases\Patent\57000-57999\PS7545.AU. l\Specis\P57545.AUI Specification 2007-I -29.doc 30/I1/07 -6 would serve to cushion and retain the endoluminal device beneath the confining sheath on a delivery catheter, as well as assist in expansion of the endoluminal device in some embodiments. 5 SUMMARY OF THE INVENTION According to one aspect of the present invention, there is provided a deployment system for an endoluminal device comprising: 10 an expandable endoluminal device mounted on a delivery catheter provided with an endo-prosthesis mounting member; a removable sheath in the form of a double-walled tube adapted to cover and constrain at least a portion of 15 said endoluminal device in an introductory profile; wherein said deployment system includes a tubular deployment line extending from said double-walled tube to which tension can be applied to aid endoluminal device deployment; 20 wherein upon endoluminal device deployment, said double-walled tube progressively unrolls from around said endoluminal device through actuation of said deployment line to form removed sheath material; wherein upon deployment, said tubular deployment 25 lines splits to form an elongated filament. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 illustrates a longitudinal cross-section of the present invention. 30 Figure lA is an enlarged view of Figure 1. Figure 2 illustrates a perspective view of the present invention. 2277499_1 (GHMancrs) 14/05/10 -6a Figure 3 illustrates a longitudinal cross-section of the present invention. Figure 3A is an enlarged view of Figure 3. Figure 4 illustrates a longitudinal cross-section of s the present invention. Figure 4A is an enlarged view of Figure 4. Figure 5 illustrates a longitudinal cross-section of the present invention. Figure 5A is an enlarged view of Figure 5. 10 Figure 6 illustrates a longitudinal cross-section of the present invention. Figure 6A is an enlarged view of Figure 6. 2277499_1 (GHMatters) 14/05/10 - 7 Figure 6A is an enlarged view of Figure 6. Figure 7 illustrates a longitudinal cross-section of the present invention. Figure 7A is an enlarged view of Figure 7. 5 Figure 7B illustrates the embodiment of Figure 7A as viewed from the direction indicated by the arrow. Figure 7C illustrates the embodiment of Figure 7A as viewed from the direction indicated by the arrow. Figures 8 and 8A illustrate longitudinal cross io sections views of the present invention placed inside a vascular or cardiac structure. Figure 9 illustrates a longitudinal cross-section of the present invention with a covering placed over an endo prosthesis mounting member. 15 Figure 9A illustrates a longitudinal cross-section of the present invention without a covering placed over an endo-prosthesis mounting member. Figure 10 illustrates a longitudinal cross-section of the present invention with an endo-prosthesis mounting 20 member placed between an underlying delivery catheter and an endoluminal device. Figure 11 illustrates a longitudinal cross-section of the present invention having an outer catheter, or tube, placed over substantially the entire length of a sheath 25 deployment line construction. Figure 12 illustrates a longitudinal cross-section of the present invention showing an endoluminal device in the form of a collapsed inflatable balloon having a first dimension confined to a second dimension with a sheath 30 deployment line of the invention. Figure 13 illustrates a cross-section of the present invention showing an active elastic element attached to the sheath portion of the present invention as a means to remove the sheath from around an endoluminal device. 35 N:\Meiboume\Cascs\Patent\57000-57999\P57545 AU l\Specis\P57545.AU I Specification 2007-11-29doc 30/11/07 - 8 DETAILED DESCRIPTION OF THE INVENTION The present invention is directed to a deployment system for an endoluminal device having a removable sheath with a deployment line or filament that is an integral 5 part of the sheath. As indicated by the relative difference in the space between the "x" arrows and the "y" arrows in Figure 12, the sheath portion (12) confines the endoluminal device (18a) to a smaller profile than is possible without the sheath. The sheath radially confines 10 the endoluminal device in a compacted or collapsed configuration during storage and introduction into a patient's vascular system. The confining sheath maintains the endoluminal device in a compacted configuration until the device is delivered with a catheter to an implantation 15 site in a vascular or cardiac structure. At the time of deployment, the sheath is retracted from the endoluminal device. In some embodiments, sheath material may be converted into deployment line material as the sheath is removed from the endoluminal device. As the sheath is 20 removed from the endoluminal device, the endoluminal device is free to expand. Once free from the confining sheath, the endoluminal device may expand spontaneously or with the assistance of an inflatable balloon. Any remaining sheath material may be removed from the 25 implantation site along with the deployment line. The integral sheath - deployment line is preferably a flexible polymeric material that is continuous along the length of the construct. Preferably, the physical and mechanical properties of the sheath portion are such that 30 they are uniform and homogeneous throughout the length of the sheath portion used to constrain the endoluminal device. Since most endoluminal devices are generally circularly cylindrical in form, the sheath is preferably tubular in shape in order to enclose most or all of the 35 endoluminal device. Conical, tapered, or other suitable shapes for the sheath are also contemplated in the present invention. Flexibility of the sheath is enhanced by N:\Melboumc\Cases\Patcnt\57000-57999\P57545 AU \Spccis\P57545 AU I Specification 2007-I 1-29doc 30/11/07 -9 making the walls of the sheath as thin as practicable. In one embodiment of the present invention (20), the tubular sheath portion (12a) of the sheath - deployment line has a single wall (Fig. 3). The deployment line portion can 5 extend from either end of the single-walled sheath (12a). When the sheath portion is retracted from around an endoluminal device, the length of retracted sheath is substantially equal to the length of deployment line displaced during deployment of the endoluminal device. 10 In another embodiment of the present invention (10), the sheath portion (12) of the sheath - deployment line has a double wall (Figs. 1, 2, and 4 - 11). In a preferred embodiment, the double walled-sheath portion (12) is made of a polymeric material that is folded on 15 itself. The double-walled sheath portion is placed over the endoluminal device (14) so that the fold (22) is positioned at the distal end (i.e., farthest from the control knob) of the sheath portion (12). The inner wall of the sheath portion may be anchored to part of an 20 underlying delivery catheter (19) proximal to the endoluminal device (14). In preferred embodiments, the sheath portion (12) is not attached to the delivery catheter (19). The proximal end of the outer wall of the sheath has at least one portion, or integral extension, 25 that is convertible to deployment line (16). Space between the walls of the double-walled sheath portion can be filled with fluids, lubricants, pharmaceutical compositions, and/or combinations thereof. The deployment line (16) is routed through the delivery catheter (19) to 30 a control knob (not shown) located at the proximal end of the deployment system (10). Alternatively, a separate catheter (13) or catheter lumen (11) is provided for the deployment line (Figs 4 and 1, respectively). These embodiments provide additional containment of the 35 deployment line portion, particularly when bends or curves in a patient's vasculature having small radii are anticipated. In the most preferred embodiment (Fig. 11), N \Melboumc\Cases\Patent\57000-57999\P57545.AU I\Specis\P57545.AU.A Specification 2007-11-29 doc 30/11/07 - 10 the sheath portion of the sheath - deployment line construction extends substantially the entire length of the delivery catheter (19) and is confined within a separate catheter (19a) or catheter lumen. The deployment 5 line portion is formed near the proximal end of the deployment system and is attached to a control knob (not shown). Preferably, the physical and mechanical properties of the sheath portion are such that they are uniform and 10 homogeneous throughout the length of the sheath portion used to constrain the endoluminal device. When the sheath portion is retracted from around an endoluminal device, the length of retracted sheath is essentially half the length of deployment line displaced during deployment of is the endoluminal device. This two to one ratio of length of deployment line removed to length of sheath material removed reduces the effect of too rapid or strong a pull on the deployment line on release of the endoluminal device from the sheath. 20 Fluoropolymer materials are preferred for making the retractable tubular constraining sheath - deployment line constructs of the present invention. Fluoropolymer materials used in the present invention are strong, thin, and lubricious. The lubriciousness of the fluoropolymer 25 materials is especially advantageous in embodiments utilizing a sheath - deployment line having walls that slide past one another or over an endoluminal device. Particularly preferred fluoropolymer materials are porous expanded polytetrafluoroethylene materials alone or in 30 combination with fluorinated ethylene propylene materials. Most preferred fluoropolymer materials are strong and thin, such as those described in Example 2, infra. The sheath - deployment line is made by constructing an appropriate tube from layers of film and/or membrane. The 35 sheath-deployment line may also be constructed from extrusions of polymeric materials. The extrusions can be used alone or in combination with film/membrane materials. N:\Melboume\Cascs\Patent\57000-57999\P57545.AU I\Specis\P57545.AU I Specification 2007-11-29.doc 30/11/07 - 11 Once constructed, a significant portion of the tube is rendered filamentous by rolling and heating. The sheath may be converted to deployment line by pulling on the deployment line and causing the sheath S material to separate and converge into a single filament. As sheath material is converted to deployment line by this process, the edge of the sheath supplying material to the deployment line recedes causing the sheath to retract from around the endoluminal device. As a portion of the sheath 10 retracts, the portion of the endoluminal device confined by the sheath is freed to expand (Figs 8 - 8A). Means are optionally provided to the deployment system that initiate or sustain the conversion of sheath to deployment line. As shown in Figure 7, the means include perforations (71), 15 cutouts (72), or other engineered defect introduced into the sheath material. As shown in Figure 5, the means also include cutters (21) or other sharp edges on the delivery catheter. Such cutting means may be formed on the delivery catheter by exposing a strand of reinforcing 20 stainless steel from within the catheter and adapting the strand to cut into the sheath portion. In the preferred embodiment of the present invention, materials, composites, constructions, and/or assemblies exhibiting compliance, compressibility, resilience, and/or 25 expandability are placed between the endoluminal device and the delivery catheter to form an "endo-prosthesis mounting member (18)." The endo-prosthesis mounting member can be covered (15) or uncovered (Fig. 9). At least a portion of the endoluminal device is pressed into 30 a covered or uncovered endo-prosthesis mounting member to anchor the endoluminal device on the delivery catheter and prevent the endoluminal device from moving along the length of the catheter. Materials with a tacky surface are useful with the endo-prosthesis mounting member, 35 particularly in combination with a lubricious sheath material. The endo-prosthesis mounting member eliminates the need for barrier, or retention, means placed at the N \Melboumc\Cases\Patent\57000-57999\P57545 AU. I\Specis\P57545AU.I Specification 2007-11-29 doc 30/11/07 - 12 proximal and distal end of the endoluminal device. In addition to added flexibility imparted to the deployment system without the barrier means, the profile of the sheath and endoluminal device combination is reduced 5 without the barrier means. In yet another embodiment, the endo-prosthesis mounting member is in the form of an inflatable balloon (Fig 10, part 18a). Suitable materials for the endo-prosthesis mounting member include, but are not limited to, silicones, silicone foams, polyurethane, 10 polyurethane foams, and polytetrafluoroethylene foams or combinations thereof. The endo-prosthesis mounting member is attached to the outer wall of the delivery catheter with adhesives, heat, or other suitable means. A non-inflatable endo-prosthesis mounting member is 15 preferably enclosed with a covering (15) in the form of a polymeric material. The polymeric material is preferably a fluoropolymer-based material. Porous expanded polytetrafluoroethylene is the preferred fluoropolymer for enclosing the compressible material. Other suitable 20 polymeric materials include, but are not limited to, silicone, polyurethane, polyester, and the like. Examples 25 Example 1 This example describes the construction of a deployment system of the present invention. Construction of the system began with the preparation of a distal catheter shaft for receiving an expandable stent. Once 30 the distal catheter was prepared, the expandable stent was placed within a sheath - deployment line. The distal catheter portion of this combination was attached to a primary catheter shaft. The deployment line portion was then routed through the primary catheter to a control 35 knob. The control knob was part of a hub located proximally on the primary catheter. The sheath portion of N:\Melbourne\Cases\Patent\57000-57999\P57545 AU.\Specis\P57545AU. I Specification 2007-II-29.doc 30/11/07 - 13 the sheath - deployment line was in the form of a single walled tube. A tubular material three inches long was obtained from Burnham Polymeric, Inc., Glens Falls, NY for use as 5 the distal catheter shaft. The tube was made of a polyether block amide material, commonly known as PEBAX* resin and reinforced with a stainless steel braid. The outer diameter (OD) was 1.01mm and the inner diameter (ID) was 0.76mm. An endo-prosthesis mounting member in the 10 form of a compressible material was then placed on the catheter. To place the endo-prosthesis mounting member on the catheter, the catheter was mounted on a mandrel having an outer diameter of 0.74mm. A film of porous expanded 15 polytetrafluoroethylene (ePTFE) was obtained according to the teachings in U.S. Patent No. 5,814,405, issued to Branca, which is incorporated herein by reference. A discontinuous coating of fluorinated ethylene propylene (FEP) was applied to one side of the ePTFE material in 20 accordance with U.S. Patent No. 6,159,565, issued to Campbell et al., and incorporated herein by reference. An edge of the ePTFE - FEP composite film two inches wide was attached with heat to the catheter shaft. After initial attachment, the film was wrapped around the catheter shaft 25 forty-five (45) times under light tension. With every fifth wrap of the film, and on the final layer, the film is further attached to itself with heat supplied by a soldering iron. This procedure provided a endo-prosthesis mounting 30 member in the form of a compressible material, or compliant "pillow," on the distal catheter shaft. The expandable stent was mounted over the endo-prosthesis mounting member. The endo-prosthesis mounting member provides a means of retaining an expandable stent on the 35 catheter shaft during storage, delivery to an implantation site, and deployment of the expandable stent at the implantation site. Optionally, the endo-prosthesis N-\Melboume\Cascs\Patent\57000-57999\P57545.AUWl\Specis\PS7545 AU ISpecification 2007-11-29 doc 30/11/07 - 14 mounting member may be reinforced with a thin coating of an elastomeric material such as silicone, urethane, and/or a fluoroelastomer. An eight (8) cell, 6mm diameter, nitinol stent was 5 obtained from Medinol Ltd., Tel-Aviv, Israel. The stent was placed over the endo-prosthesis mounting member of the catheter in an expanded state. The combination was placed within a machine having a mechanical iris that compacts or compresses the stent portion of the assembly onto the 10 endo-prosthesis mounting member. While retained in the mechanical iris machine, the stent was reduced in temperature from room temperature (c. 220C) to approximately five degrees centigrade (50C). At the reduced temperature, the iris machine was actuated to 15 compact, or collapse, the stent onto the endo-prosthesis mounting member. While in the refrigerated and compressed configuration, the catheter, endo-prosthesis mounting member, and stent were placed within a sheath - deployment line of the present invention. 20 The sheath - deployment line having a length equal to, or greater than, the length of the final deployment system was made as follows. A length of stainless steel mandrel (c. 1m) measuring 1.89mm in diameter was covered with a tubular extruded ePTFE material having an overall 25 length of about 200cm. The tubular ePTFE material had an outer diameter of 1.41mm, a wall thickness of 0.05mm, and an average longitudinal tensile strength of 3.52kgf with an average circumferential strength of 0.169kgf. The tubular ePTFE material also had an average mass/length of 30 0.0473g/ft with an average Matrix Tensile Strength of 69,125 PSI. At one end (proximal end), the tubular ePTFE material was bunched together on the mandrel, while the opposite end (distal end) of the ePTFE material remained smooth on the mandrel. 35 The first few centimetres of the tubular ePTFE material was sacrificed and the next 5cm of the distal end (smoothed end) of the extruded ePTFE material was then N:\Mclboume\Cases\Patent\57000-57999\P5754SAU ISpecis\P57545AU I Specification 2007-1 I-29.doc 30/1I/07 - 15 reinforced with a composite fluoropolymer material as follows. The ePTFE-covered mandrel was attached to retaining chucks on a film-wrapping machine. A first reference line located approximately 5cm from the end of 5 the smooth portion of the extruded ePTFE material was circumferentially drawn around the material with a permanent marker (SHARPIE*). A 5cm wide composite membrane made of expanded polytetrafluoroethylene (ePTFE) and fluorinated ethylene propylene (FEP) was applied io proximal from the first reference line on the extruded ePTFE material so the FEP portion of the composite membrane was against the extruded ePTFE material. The composite membrane was wrapped around the ePTFE covered mandrel two times so that the primary strength of the 15 extruded ePTFE material was oriented perpendicular to the longitudinal axis of the mandrel. The composite membrane was initially tacked in place on the extruded ePTFE material with heat applied from a soldering iron. The composite ePTFE/FEP material had a density of about 20 2.14g/cm 3 , a thickness of 0.005mm, and tensile strengths of about 340 KPa (about 49,000 psi) in a first direction and of about 120 KPa (about 17,000 psi) in a second direction (perpendicular to the first direction). The tensile measurements were performed on an Instron Tensile Machine 25 (Instron Corporation, Canton, MA) at 200mm/min. load rate with 2.5cm (one inch) jaw spacing. Material of the sheath - deployment line construction adjacent to the reinforced portion was smoothed out along the mandrel and a second reference line was drawn around 30 the material 5cm from the first reference line. A second portion of the sheath - deployment line construction was reinforced as follows. A second reference line was drawn around the extruded ePTFE material 5cm from the proximal end of the first reinforced 35 portion. Using the second reference line to align a 2cm wide strip of the above-mentioned ePTFE/FEP composite membrane, the composite membrane was wrapped once around N:\Melboume\Cases\Patent\57000-57999\P57545A U I\Specis\P57545.AU I Specification 2007-11-29.doc 30/t 1/07 - 16 the remaining portion of the extruded ePTFE material to form a second reinforced portion of the sheath deployment line of the present invention. The second reinforced portion was about 2cm in length. The composite 5 reinforcing membrane material was attached to the extruded ePTFE material as described above, with the exception that the major strength component of the material was parallel to the axis of the mandrel. Any air trapped in the construction was removed by 10 applying a sacrificial layer of ePTFE tightly around the construction. A one inch (2.54cm) wide film of ePTFE was helically overwrapped around the reinforced portion of the construction. Two layers of the ePTFE film were applied in one direction and two layers were applied in the 15 opposite direction. The construction with sacrificial layers were then placed in an oven heated to 320 0 C for eight minutes. Upon removal from the heated oven, the combination was allowed to cool to room temperature. The sacrificial ePTFE material was then removed. 20 The construction was then removed from the mandrel and another mandrel (1.83mm diameter X 30.5cm long) inserted into the reinforced end of the construction. With the mandrel supporting the reinforced end, a 5mm long slit was made proximal to the reinforced portion of the 25 sheath - deployment line construction. A second mandrel was placed inside the construction up to the 5mm slit where it exited the construction. The proximal portion of the sheath - deployment line construction was converted into a filament by placing the proximal end into the 30 chucks of the film wrapper chucks and rotating the film wrapper approximately 2,800 times while the mandrel with the reinforced construction was immobilized. After the construction was spun into a filament, the filament was strengthened by briefly applying heat to the filament with 35 a soldering iron set at 450 0 C. The strengthened filament was smoothed and rendered more uniform in diameter by passing the filament over a 1.8cm diameter X 3.8cm long N \Mclbourne\Cases\Patent\57000-57999\P57545.AU I\Spccis\P57545 AU I Specification 2007-1 1-29.doc 30/11/07 - 17 dowel heated to approximately 3200C. The filament was passed over the heated dowel at a 450 angle under slight tension. This process was repeated two more times over the entire length of the filament. 5 The filament portion of the sheath - deployment line of the present invention was routed through a lumen of a primary catheter and connected to a control knob. The control knob was part of a hub located at the proximal end of the primary catheter. When the deployment line portion 10 of the sheath - deployment line was pulled, the sheath portion was retracted from around the stent. Example 2 This example describes the construction of a 15 deployment system of the present invention. Construction of the system begins with the preparation of a distal catheter shaft for receiving an expandable stent. Once the distal catheter was prepared, the expandable stent was placed within a sheath - deployment line. The distal 20 catheter portion of this combination was attached to a primary catheter shaft. The deployment line portion was then routed through the primary catheter to a control knob. The control knob was part of a hub located proximally on the primary catheter. The sheath portion of 25 the sheath - deployment line was in the form of a double walled tube. A tubular material three inches long was obtained from Burnham Polymeric, Inc., Glens Falls, NY for use as the distal catheter shaft. The tube was made of a 30 polyether block amide material, commonly known as PEBAX* resin and reinforced with a stainless steel braid. The outer diameter (OD) was 1.01 mm and the inner diameter (ID) was 0.76 mm. A endo-prosthesis mounting member in the form of a compressible material was then placed on the 35 catheter. To place the endo-prosthesis mounting member on the catheter, the catheter was mounted on a mandrel having an outer diameter of 0.74 mm. A film of porous expanded N \Melboume\Cases\Patent\57000-57999\P57545 AU I\Specis\P57545.AU I Spccification 2007-11-29.doc 30/11/07 - 18 polytetrafluoroethylene (ePTFE) was obtained according to the teachings in U.S. Patent No. 5,814,405, issued to Branca, which is incorporated herein by reference. A discontinuous coating of fluorinated ethylene propylene s (FEP) was applied to one side of the ePTFE material in accordance with U.S. Patent No. 6,159,565, issued to Campbell et al., which is incorporated herein by reference. An edge of the ePTFE - FEP composite film two inches wide was attached with heat to the catheter shaft. 10 After initial attachment, the film was wrapped around the catheter shaft forty-five (45) times under light tension. With every fifth wrap of the film, and on the final layer, the film is further attached to itself with heat. This procedure provides a endo-prosthesis mounting member on is the distal catheter shaft. The expandable stent is mounted over the endo-prosthesis mounting member. The endo-prosthesis mounting member provides a means of retaining an expandable stent on the catheter shaft during storage, delivery to an implantation site, and deployment 20 of the expandable stent at the implantation site. Optionally, the endo-prosthesis mounting member may be reinforced with a thin coating of an elastomeric material such as silicone, urethane, and/or a fluoroelastomer. An eight (8) cell, 6mm diameter, nitinol stent was 25 obtained from Medinol Ltd., Tel-Aviv, Israel. The stent was placed over the endo-prosthesis mounting member of the catheter in an expanded state. The combination was placed within a machine having a mechanical iris that compacts or compresses the stent portion of the assembly onto the 30 endo-prosthesis mounting member. While retained in the mechanical iris machine, the stent was reduced in temperature from room temperature to approximately five degrees centigrade (5 0 C). At the reduced temperature, the iris machine was actuated to compact, or collapse, the 35 stent onto the endo-prosthesis mounting member. While in the refrigerated, compressed configuration, the catheter, endo-prosthesis mounting member, and stent were placed N:\Melbournc\Cases\Patcnt\57000-57999\P57545 AU. I\Specis\P57545.AU. I Specification 2007-11-29.doc 30/11/07 - 19 within a sheath - deployment line of the present invention. The sheath - deployment line having a length equal to, or greater than, the length of the final deployment 5 system was made as follows. A stainless steel mandrel measuring 1.73 mm in diameter was covered with a sacrificial layer of ePTFE. The sacrificial ePTFE material aids in removal of the sheath - deployment line from the mandrel. Two wraps of a thin, 10 polytetrafluoroethylene (PTFE) membrane were applied to the mandrel. The ePTFE membrane was applied so the primary strength of the film was oriented parallel with the longitudinal axis of the mandrel. The film was initially tacked in place with heat applied with a soldering iron. 15 The membrane thickness measured about 0.0002" (0.005 mm) and had tensile strengths of about 49,000 psi (about 340 KPa) in a first direction and of about 17,000 psi (about 120 KPa) in a second direction (perpendicular to the first direction). The tensile measurements were 20 performed at 200mm/min. load rate with a 1" (2.5 cm) jaw spacing. The membrane had a density of about 2.14g/cm 3 . The membrane was further modified by the application of an FEP coating on one side in accordance with U.S. Patent No. 6,159,565, issued to Campbell et al., which is 25 incorporated herein by reference. Next, two wraps of another ePTFE film made according to the teachings of Bacino in U.S. Patent No. 5,476,589 and further modified with a discontinuous layer of an FEP material applied to one side of the ePTFE film were applied to one end of the 30 construction (approx. 1" wide). U.S. Patent No. 5,476,589 is incorporated herein by reference. These two wraps had the primary strength direction of the film oriented perpendicular to the mandrel's longitudinal axis. These layers of film provide additional "hoop" or "radial" 35 strength to the sheath - deployment line construct. The mandrel and sheath - deployment line construct were placed in an air convection oven obtained from The Grieve N \Melboumc\Cases\Patent\57000-57999\P57545.AUI. \Specis\PS7545.AU.I Specification 2007-1 1-29doc 30f 11/07 - 20 Corporation, Round Lake, IL, and subjected to a thermal treatment of 320*C for 12 minutes. After air cooling, the ePTFE/FEP tube construct was removed from the mandrel and the sacrificial ePTFE layer removed. In this example, a 5 length of sheath - deployment line extending beyond the end of the stent was provided. The additional length of sheath - deployment line was folded back over sheath portion enclosing the stent to form a double-walled construct. The double-walled sheath - deployment line had 10 an inner wall and an outer wall. The inner wall was against the stent and the outer wall included the integral deployment line portion of the construct. The construct was then attached to a primary catheter shaft using heat and standard materials. 15 The deployment line portion of the sheath deployment line was made by splitting the sheath deployment line along its length from a proximal end up to, but not including, the sheath portion enclosing the stent. The material thus obtained was gathered into a 20 filament by rolling the material. Heat was applied to the material to set the material in the filamentous form. The deployment line filament was routed through a lumen in the primary catheter and connected to a control knob. The control knob was part of a hub located at the proximal end 25 of the primary catheter. When the deployment line portion of the sheath - deployment line was pulled, the sheath portion was retracted from around the stent. Example 3 30 This example describes the incorporation of a means for initiating or maintaining conversion of the sheath portion of the sheath - deployment line to deployment line by introducing perforations and intentional stress risers into the sheath. 35 The sheath - deployment line from Example 2 is modified as follows. Prior to rolling the sheath portion into a double-walled construct and loading the stent N:\Mclboume\Cases\Patem\57000-57999\P57545.AU.\Spccis\P57545.AU. Specification 2007-1 1-29.doc 30/11/07 - 21 therein, the sheath is perforated and/or supplied with "stress risers" that facilitate in separation of the tubular sheath upon retraction of the deployment line portion. An appropriate laser for making the perforations 5 or stress risers is a 20 watt CO 2 laser obtained from Universal Laser Systems, Scottsdale, AZ. To form the perforations in the sheath portion, the sheath is placed on a sandblasted stainless steel mandrel and exposed to the laser to cut a series of holes in a part of the tube io that will subsequently serve as the outer wall of the double-walled construct. The geometry of the holes can be varied depending on the application. The perforated sheath portion is used on a deployment line system of the present invention as described in Example 2. In this 15 example, tension applied to the deployment line portion at the hub end of the catheter results in retraction of the sheath from around the stent and also results in parting the sheath at the perforations. As the sheath portion is separated, the sheath material becomes convertible to 20 deployment line. Example 4 This example describes the incorporation of a means for initiating or maintaining conversion of the sheath 25 portion of the sheath - deployment line to deployment line by the use of an appropriate splitting means. The primary catheter from Example 2 is modified as follows. The primary portion of the catheter is provided with a notch in the wall in 180 degrees opposition and 30 slightly distal to the entry point of the deployment line portion into the catheter lumen. The notch is further modified to provide a small cutting edge in the notch. In one embodiment, the cutting edge is simply attached to the notch with heat, adhesives, and the like. In another 35 embodiment, the cutting edge is formed by exposing a portion of a metallic braid used to reinforce the catheter shaft and forming the braid into a cutting edge. In this N \Melboume\Cases\Patent\57000-57999\P57545AU. l\Specis\P57545 AU. I Specification 2007-I1-29.doc 30/11/07 - 22 example, tension applied to the deployment line portion at the hub end of the catheter results in retraction of the sheath from around the stent and also results in parting the sheath at the perforations. As the sheath portion is 5 separated, the sheath material becomes convertible to deployment line. Example 5 This example describes the construction of a 10 deployment system of the present invention for use in the delivery and deployment of both self-expanding as well as balloon expandable devices. The deployment system of this example utilizes an endo-prosthesis mounting member in the form of an inflatable balloon. 15 A sheath - deployment line having a length equal to, or greater than, the length of the final deployment system is made as follows. A stainless steel mandrel measuring 1.73 mm in diameter is covered with a sacrificial tube of ePTFE. The sacrificial ePTFE material aids in removal of 20 the sheath - deployment line from the mandrel. Two wraps of a thin, polytetrafluoroethylene (PTFE) membrane is applied to the mandrel. The ePTFE membrane is applied so the primary strength of the film is oriented parallel with the longitudinal axis of the mandrel. The film is 25 initially tacked in place with heat applied with a soldering iron. The membrane thickness measured about 0.0002" (0.005 mm) and had tensile strengths of about 49,000 psi (about 340 KPa) in a first direction and about 17,000 psi (about 120 KPa) in a second direction 30 (perpendicular to the first direction). The tensile measurements are performed at 200mm/min. load rate with a 1 inch (2.5 cm) jaw spacing. The membrane has a density of about 2.14g/cm. The membrane is further modified by the application of a fluorinated ethylene propylene (FEP) 35 coating on one side in accordance with U.S. Patent No. 6,159,565, issued to Campbell et al. and incorporated herein by reference. Next, two wraps of another ePTFE N:\Melboumc\Cases\Patent\57000-57999\P57545AU. I\Spccis\P57545.AU ISpecification 2007-11-29.doc 30/11/07 - 23 film made according to the teachings of Bacino in U.S. Patent No. 5,476,589, which is incorporated herein by reference, and further modified with a discontinuous layer of an FEP material applied to one side of the ePTFE film 5 are applied to one end of the construction (approx. 1" wide). These two wraps have the primary strength direction of the film oriented perpendicular to the mandrel's longitudinal axis. These layers of film provide additional "hoop" or "radial" strength to the sheath 10 deployment line construct. The mandrel and sheath deployment line construct are placed in an air convection oven obtained from The Grieve Corporation, Round Lake, IL, and subjected to a thermal treatment of 320 0 C for 12 minutes. After air cooling, the ePTFE/FEP tube construct 15 is removed from the mandrel and the sacrificial ePTFE layer removed. Placement of this construct over an expandable stent and formation of a deployment line portion therefrom is described below. As seen in Figure 10, a balloon expandable NIRflexTM 20 stent (14), available from Medinol Ltd, Tel-Aviv, Israel, is placed over and compacted around a deflated and collapsed angioplasty balloon mounted on a delivery catheter shaft (19). The angioplasty balloon is made in accordance with US 5,752,934 to Campbell et al., which is 25 incorporated herein by reference, and available from W.L. Gore & Associates, Inc., Flagstaff, AZ under the tradename APTERA* angioplasty balloon. The APTERA* angioplasty balloon serves as an endo-prosthesis mounting member (18a) for receiving and retaining the compacted 30 stent (14). While the stent is confined in a compacted configuration, a length of sheath - deployment line (12) is placed over the compacted stent and extended beyond the end of the stent. The additional length of sheath 35 deployment line is folded back over sheath portion enclosing the stent to form a double-walled construction. The double-walled sheath - deployment line has an inner N:\Melboume\Cases\Patent\57000-57999\P57545 AU. l\Specis\P57545.AU.I Spccification 2007-11-29.doc 30/11/07 - 24 wall and an outer wall. The inner wall is against the stent and the outer wall includes the integral deployment line portion of the construct. The deployment line portion of the sheath 5 deployment line is made by splitting the sheath deployment line along its length from the proximal end toward the distal end for a distance. The slit can range in length from about one centimetre to substantially the entire length of the sheath - deployment line construction 10 up to, but not including, the sheath portion enclosing the stent. It is preferred to form the deployment line portion near the proximal end of the delivery catheter. The material thus obtained is gathered into a filament by rolling the material. Heat is applied to the material to 15 set the material in the filamentous form. The sheath deployment line is routed through a dedicated lumen in the delivery catheter and exits at a hub where the deployment line portion is attached to a control knob. The control knob is part of a hub located at the proximal end of the 20 primary catheter. When tension is applied to the deployment line portion of the sheath - deployment line, the sheath portion retracts from around the stent. Removal of the sheath portion from the underlying stent frees the stent to expand. The NIRflexT stent of this 25 example is expanded by inflating the APTERA* angioplasty balloon. Once the stent is expanded, the balloon is deflated and the delivery catheter along with the sheath deployment line construction removed from the implant recipient. When self-expanding stents are used in the 30 present invention, the balloon is useful as an endo prosthesis mounting member. In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary 35 implication, the word "comprise" or variations such as "comprises" or "comprising" is used in an inclusive sense, i.e. to specify the presence of the stated features but N:\Melboume\Cases\Patent\57000-57999\P57545.AU l\Spccis\P57545.AU I Specifcation 2007- 1-29.doc 30111/07 - 25 not to preclude the presence or addition of further features in various embodiments of the invention. It is to be understood that, if any prior art publication is referred to herein, such reference does not 5 constitute an admission that the publication forms a part of the common general knowledge in the art, in Australia or any other country. N \Melbourne\Cases\Patent\57000-57999\PS7545.AU.l\Specis\P57545.AU I Spccification 2007-11-29 doc 30/11/07

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6059813A (en) * 1998-11-06 2000-05-09 Scimed Life Systems, Inc. Rolling membrane stent delivery system
WO2001024733A1 (en) * 1999-10-01 2001-04-12 Boston Scientific/Scimed Life Systems, Inc. Balloon yielded delivery system and endovascular graft design for easy deployment
US6447540B1 (en) * 1996-11-15 2002-09-10 Cook Incorporated Stent deployment device including splittable sleeve containing the stent

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6447540B1 (en) * 1996-11-15 2002-09-10 Cook Incorporated Stent deployment device including splittable sleeve containing the stent
US6059813A (en) * 1998-11-06 2000-05-09 Scimed Life Systems, Inc. Rolling membrane stent delivery system
WO2001024733A1 (en) * 1999-10-01 2001-04-12 Boston Scientific/Scimed Life Systems, Inc. Balloon yielded delivery system and endovascular graft design for easy deployment

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